Job Descriptions
- Assist the department head of Quality in the implementation of and maintenance of the Company Quality Management Systems (QMS) in accordance with ISO 13485 standard and other applicable regulatory requirements.
- Assist the department head of Quality to coordinate external audits conducted by customers and notified/ regulatory bodies. Work with various departments to ensure timely closure of any audit findings or observations.
- Coordinate Engineering Change activities in compliance with Engineering Change procedure and ensure correct revision of drawings, specifications, and documents.
- Ensure all quality documents and records are kept in compliance with Document Control and Record Control procedures.
- Conduct New Employees’ Orientation (NEO) Training on Quality Policy, Quality Objectives, Good Documentation Practice and Data integrity, Document Control and Record Control.
- Consolidate quality data, quality issues and trends for monthly quality metrics reporting.
- Assist department Head of Quality to prepare Management Review semi-annually.
- Track CAPA and any actions arising from Internal Audit, coordinate with responsible parties to ensure timely closure of action items.
- Liaise with 3rd party Notification or Regulatory Bodies for certification and regulatory activities. Track and monitor Regulatory Bodies, such as FDA/ HAS for regulatory updates or any changes to their requirements.
- Perform other tasks as assigned by the Supervisor
Requirement:
- Diploma in Engineering, Science or equivalent
Experience:
- Minimum 1 year working experience in quality management systems and applications.
- Knowledge and experience working within a regulated and structured environment.
- Work experience as Quality System Executive in a medical device manufacturing environment. (Candidates with more experience can be considered for Senior Quality System Executive position)
- Experience with handling ISO13485 audit as an auditee
Skills :
- ISO13485 Internal Auditor
- Root cause analysis (Kepner- Tregoe, 5-Why, 6M etc)
- Problem solving techniques (eg: DMAIC/8D/PDCA/A3 application in continuous improvement)
- Competent with general PC and office software application
- Proficiency in MS Office.
